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Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure

NCT06310031 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2026-04-01

No results posted yet for this study

Summary

The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

Conditions

Interventions

DEVICE

BrioVAD System

Implantation of the BrioVAD System to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure.

DEVICE

HeartMate 3

Implantation of the commercially approved HeartMate 3 LVAS, which is the standard treatment for advanced heart failure.

Sponsors & Collaborators

  • BrioHealth Solutions, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2028-02-29
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06310031 on ClinicalTrials.gov